Objective: To examine the efficacy of two sessions of Early EMDR therapy between day 14 and day 28 post-rape on the reduction of PTSD (symptoms) at 12 weeks post-rape. The main research question is:Do victims of rape report significantly less PTSD…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the participants* level of PTSD symptom severity.
Secondary outcome
Secondary measures include the degree of dissociation, memory representation,
vividness and emotional intensity of the images during recall in the Early EMDR
condition and the participants* level of comorbid psychopathology, with special
attention to depression and sexual problems.
Background summary
After experiencing rape, the risk of developing post traumatic stress disorder
(PTSD) is high, with rates up to 40% three months post-rape (Möller, Bäckström,
Torbjörn, Söndergaard & Helström, 2014; Rothbaum et al., 1992). As PTSD
constitutes a major individual, societal and economic burden (Thielen et al.,
2016; Olff et al., 2005), the prevention of PTSD gained much attention in
recent decades. However, at present, there is no clear evidence-based
preventive intervention for acutely traumatized individuals (Rose et al., 2002;
Sijbrandij et al., 2006; Qi, Gevonden & Shalev, 2016). Clinical guidelines and
expert consensus mainly suggest what not to do in the acute aftermath of trauma
(NICE, 2005). At the same time, there is an urgent call for new initiatives in
early interventions for trauma survivors, especially for incorporating existing
evidence-based techniques into preventive interventions. In this study, we will
investigate whether Eye Movement Desensitization and Reprocessing (EMDR)
therapy at an early stage after rape can be efficacious in reducing PTSD
symptoms. As far as we know, our study will be the first to investigate the
efficacy of EMDR as a preventive intervention for acute rape victims using an
randomize controlled trial. If the intervention proves effective, it may be
broadly applicable in clinical practice. The study will also enhance knowledge
with regard to acute psychological relief and the aftercare of rape victims.
Study objective
Objective: To examine the efficacy of two sessions of Early EMDR therapy
between day 14 and day 28 post-rape on the reduction of PTSD (symptoms) at 12
weeks post-rape.
The main research question is:
Do victims of rape report significantly less PTSD symptoms at 12-weeks follow
up, after two sessions of Early EMDR therapy compared to TAU?
Study design
The proposed study is a randomized controlled trial allocating subjects within
7 days post-rape, to either two sessions of Early EMDR Therapy or Treatment As
Usual (TAU) in the time period 2-4 weeks post-rape, including a pre-treatment
assessment at 2 weeks post-rape and post-treatment assessments at 4, 8 and 12
weeks post-rape. The participants will be assessed with regard to PTSD
(symptomatology), degree of dissociation, memory representation, sexual
problems, image vividness and emotional intensity during recall of these images
in the studied intervention, and comorbid psychopathology. The assessments have
a quantitative (structured interview and questionnaires) nature.
Intervention
The studied intervention is EMDR versus Treatment As Usual (TAU; i.e. Watchful
Waiting).
Study burden and risks
Study participation is not expected to form a risk for the participants as EMDR
therapy poses minimal strain on participants. There may be some participants in
whom the assessment questions can activate traumatic memories, but clinical
experiences, and previous research indicates that it is highly unlikely that
participants will experience psychological difficulties other than transient
emotional reactions.
All of the assessments can be completed at the participant*s home environment.
All questionnaires can be filled out online (via Research Online for
Researchers), and the researcher will go to the patient for the clinical
interview. If preferred or deemed necessary, the pre- and post-treatment
assessments can also be completed at one of the three sites. All participants
will be offered further treatment after the final assessment.
Lundlaan 6
Utrecht 3508AB
NL
Lundlaan 6
Utrecht 3508AB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet the following criteria:
- Present within 7 days post-rape at the Rape Centers in Utrecht, Leiden, Hoofddorp or Almere.
Exclusion criteria
- Age < 16
- Assault without penetration
- Cognitive disability
- Acute psychosis
- Insufficient knowledge of the Dutch language
- Current intoxication
- Severe alcohol/drug abuse (substance treatment a priority)
- Acute suicidal ideation
- Current treatment (ad admittance) for PTSD
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60551.041.17 |